A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

JRCT ID: jRCT2031230330

Registered date:06/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 22/11/2023
• Target sample size: 60
• Countries of recruitment: Australia,Japan,Belgium,Japan,Canada,Japan,France,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Portugal,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Mirikizumab IV
Administered IV
Other Name: LY3074828
-Drug: Mirikizumab SC
Administered SC
Other Name: LY3074828

Study Arms
-Experimental: Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Interventions:
Drug: Mirikizumab IV
Drug: Mirikizumab SC
-Experimental: Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Interventions:
Drug: Mirikizumab IV
Drug: Mirikizumab SC
-Experimental: Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Interventions:
Drug: Mirikizumab IV
Drug: Mirikizumab SC

Outcome(s)

• Primary Outcome: Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders [ Time Frame: Baseline to Week 52 ]

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

Males or females weighing >10 kg and >=2 and <18 years old
Have moderate to severe UC
Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment
Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report

Exclude criteria

Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis
Have immune deficiency syndrome
Previous bowel resection or intestinal surgery
Evidence of toxic megacolon
History or current evidence of cancer of the gastrointestinal tract

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05784246